Implementing a real-time PCR-based method for sterility release testing of ATMPs
Join this webinar presented by Dr Miriam Dormeyer and Yasmin Heynen, as they discuss rapid sterility testing for ATMPs using a real-time PCR-based method and how this method can be implemented in a GMP cleanroom class A.
About this webinar
Currently established rapid methods for sterility testing of advanced therapy medicinal products (ATMPs) are mostly based on growth-based processes or the detection of metabolic activities. However, the requirements for real-time measurement and the testing of cell-containing products cannot be met with most of these methods.
In contrast, the real-time polymerase chain reaction (PCR) methodology offers a sterility test on cellular products with determination of the results on the same day. The required detection limit of < 100 CFU according to USP <1071> can be met.
A particular challenge here lies in the implementation of the molecular biological method in a multi-room Grade A cleanroom environment. Practical implementation of the technique, considering the possible risk factors will be presented.
- Understand how real-time PCR can be implemented as sterility testing method for ATMPs
- Discover how Yasmin Heynen designed the setup and risk analysis for the implementation of the rapid sterility testing in a cleanroom class A
- Learn about the validation strategy at Sartorius including the authorities’ requirements for rapid microbiological methods
- Ask the experts questions about this process and benefit from their knowledge and guidance during the live event.